Kornimate/medical-research-clean huggingface dataset:
pd-1 antibody (shr-1210) plus capecitabine in patients with intrahepatic cholangiocarcinoma after surgery

Conditions: Intrahepatic Cholangiocarcinoma

Summary: shr-1210 is a humanized anti-pd-1 immunoglobulin g4 (igg4) monoclonal antibody. this is an open- label,single center,non-randomized ,single arm exploratory study . this clinical study is an investigator-initiated clinical trial(iit) .the objective of this study is to evaluate the efficacy and safety of therapy with anti-pd-1 antibody shr-1210 plus capecitabine in patients with intrahepatic cholangiocarcinoma after surgery.


Eligibility criteria:
inclusion criteria: * age:18-75 years, male or femal; * intrahepatic cholangiocarcinoma confirmed by histopathology, r0 resection was classified as stage ib, stage ii, stage iiia, stage iiib, or stage ia with histolgoic grade g3 according to ajcc tnm (8th edition, 2017); * no extrahepatic metastases; * preoperative assessment of child-pugh a，ecog performance status 0-1; * subjects with chronic hbv infection must have hbv-dna \<500 iu / ml; * functional indicators of vital organs meet the following requirements: neutrophils ≥1.5\*109/l; platelets≥50\*109/l; hemoglobin≥90g/l; alanine aminotransferase （alt） and aspartate aminotransferase （ast） ≤ 2.5 times uln,total bilirubin≤1.5 uln; international standardized ratio (inr) ≤2.3uln,creatinine ≤1.5 uln; * no tumor recurrence or metastasis was observed. exclusion criteria: * pathological diagnosis of hepatocellular carcinoma, mixed liver cancer, hilar bile duct cancer; * no anti-tumor treatment for intrahepatic cholangiocarcinoma, including chemotherapy and topical treatment, before surgery; * known history of hypersensitivity to macromolecular protein preparation or any components of the shr- 1210 formulation; * tumors are not completely removed, or postoperative pathology suggests non-intrahepatic cholangiocarcinoma or other malignant components; * subjects with any active autoimmune disease or history of autoimmune disease; * uncontrolled clinically significant heart disease, including but not limited to the following: (1) \> nyha ii congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention; * active infection or an unexplained fever \> 38.5°c during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator); * received a live vaccine within 4 weeks of the first dose of study medication; * .pregnancy or breast feeding; * decision of unsuitableness by principal investigator or physician-in- charge.

Keywords: pd-1 antibody capecitabine intrahepatic cholangiocarcinoma adjuvant therapy
quick start of highly effective contraception

Conditions: IUD; Contraceptive Implant; Contraception; Birth Control; Emergency Contraception

Summary: this project will quantify rates of contraceptive failure when unprotected intercourse occurs 6-14 days prior to initiation of highly effective reversible contraceptives (such as iud's and implants).

women seeking emergency contraception (ec) frequently report multiple recent episodes of unprotected sex. although high sensitivity urine pregnancy tests effectively rule-out pregnancy resulting from sex that occurred more than 14 days ago, clinicians are frequently concerned that pregnancy may result from unprotected sex that occurred \<14 days prior to iud placement. placement of a copper iud within 5 days of unprotected sex is a highly effective form of ec. among 52 chinese women who reported unprotected intercourse 5-7 days prior to copper iud insertion, no pregnancies occurred. however, the effectiveness of the copper iud when unprotected sex occurs 7-14 days prior to iud placement is unknown. intrauterine pregnancies rarely occur with a copper iud in place. as some clinicians are concerned about injuring a pregnancy that occurs with an iud in place, women who have had unprotected sex 7-14 days prior to requesting iud placement are typically told they must use another, less effective, contraceptive for 2+ weeks and then return to obtain an iud. to remove this barrier to emergency placement of a copper iud, we propose to study rates of pregnancy when a copper iud is placed "any time a urine pregnancy test is negative." we believe that simplifying guidance regarding the recommended timing of copper iud placement has the potential to significantly increase the number of women offered "same-day" iud service.

Eligibility criteria:
inclusion criteria: * women between the ages of 15 and 45 years who request injectable, subdermal, or intrauterine contraception, 6-14 days after having unprotected intercourse. exclusion criteria: * history of tubal ligation or hysterectomy. * positive urine pregnancy test

Keywords: highly effective contraception emergency contraception birth control larc (long acting reversible contraception) herc (highly effective contraception)
safety and efficacy of an investigational drug versus placebo in the treatment of cancer pain (0663-083)

Conditions: Bone Neoplasms

Summary: the purpose of this study is to compare the effectiveness of an investigational drug versus placebo in the treatment of metastatic bone cancer pain in patients diagnosed with breast or prostate cancer and a bone neoplasm. patients in the study will be taking opioids to treat moderate to severe pain for their bone metastases and will remain on their opioids during the entire course of the study.


Eligibility criteria:
inclusion criteria: * patients are required to have a diagnosis of breast or prostate cancer with bone involvement and moderate to severe pain that requires opioid treatment.

Keywords: arcoxia
a multi-center retrospective study with secondary use of data of tafinlar (dabrafenib) plus mekinist (trametinib) in chinese patients with braf v600 mutation positive melanoma

Conditions: BRAF V600 Mutation Positive Melanoma

Summary: this was a multi-center, observational, retrospective cohort study to evaluate the effectiveness and safety of dabrafenib in combination with trametinib in chinese patients with unresectable or metastatic braf v600 mutation positive melanoma, for mucosal melanoma patients (cohort a) and non-mucosal melanoma patients (cohort b, cutaneous and acral melanoma), separately. study population was identified as patients initiating dabrafenib plus trametinib from 01 may 2020 to 31 july 2022 who fulfilled the inclusion/exclusion criteria. the follow-up period ended at the earliest of the following: end of study observation period (i.e., 31 december 2022), death, upon withdrawal of consent or the last available record.


Eligibility criteria:
inclusion criteria: cohorts a and b: * initiated dabrafenib and trametinib combination therapy (d+t) according to approved label between 01 may 2020 and 31 july 2022 * was ≥18 years old of age at the initiation of d+t * had at least one tumor assessment after initiation of d+t * written informed consent if requested by the study site cohort a only • confirmed braf v600 mutation positive mucosal melanoma that was unresectable or metastatic cohort b only • confirmed braf v600 mutation positive non-mucosal melanoma (cutaneous and acral melanoma) that was unresectable or metastatic exclusion criteria: none specified
correlation between left ventricular global strain measured by speckle tracking echocardiography and scar burden measured by cardiac magnetic resonance imaging in patients with ischemic heart disease

Conditions: Ischemic Heart Disease

Summary: to verify whether gls and lv mechanical dispersion, measured by two-dimensional speckle-tracking echocardiography (2d-ste) correlate with lv scar burden measured by cardiac mri in patients with ischemic heart disease.

evaluation of presence, localization, and extent of left ventricular(lv) scar tissue in patients with ischaemic heart disease (ihd) is of fundamental importance in clinical practice. it affects the decision making regarding revascularization and is a determinant of subsequent mortality. (mele, fiorencis et al. 2016) late gadolinium contrast-enhanced cardiac magnetic resonance (lge-cmr) is considered the current gold standard technique for assessment of the scar burden in ihd patients. however, it is not readily accessible in many areas due to availability and cost issues.(abou, prihadi et al. 2020), (bendary, afifi et al. 2019) several recent studies suggested 2-d speckle tracking strain as a potential surrogate for cardiovascular magnetic resonance (cmr) late gadolinium enhancement (lge) imaging. this would be useful in cases where cmr is not available, gadolinium contrast is contraindicated, or in patients at greater risk of adverse long term events. (erley, genovese et al. 2019) among echocardiography derived strain measurements, global longitudinal strain (gls) was shown to be superior to global circumferential strain (gcs) in its ability to detect subtle myocardial abnormalities due to better reproducibility (erley et al, 2019). left ventricular mechanical dispersion (lvmd) is also considered a valuable parameter that was associated with outcomes after myocardial infarction. (abou, prihadi et al. 2020). despite the growing number of strain related studies in the literature, it is not clear whether the relationship of strain measurements with lge is strong enough for strain to be considered as a surrogate. (erley, genovese et al. 2019). also, the differences between gls and lv md among strain components in this context are not well established.

Eligibility criteria:
inclusion criteria: * • patients presenting for viability assessment in to cardiac mri unit, assiut university heart hospital, with a history of previous stemi, at least 3 months after the acute event ( scar stabilization) and up to one year exclusion criteria: * patients with: * contraindication to cardiac mri (claustrophobia, patients with egfr below 30 ml/min/1.73 m2. and patients with metallic implants) * non-ischemic cardiomyopathy. * valvular heart disease (vhd).
memantine and comprehensive, individualized, patient centered management of alzheimer's disease: health outcome

Conditions: Alzheimer Disease

Summary: this study is a retrospective review of the data collected in a previously completed randomized, controlled trial (rct) entitled "memantine and comprehensive, individualized, patient centered management of alzheimer's disease: a randomized controlled trial" (nct00120874). as part of the previously completed rct, participants with alzheimer's disease (ad) were randomly placed into one of two groups: memantine, or memantine plus an individualized management program consisting of home visits, educational sessions for caregivers, and a caregiver support group. participants received the study intervention for 28 weeks; study follow-up lasted for 52 weeks. the collected data from the existing study books from the 28 week treatment portion of the rct will be carefully examined with respect to each of the research questions for the present retrospective study.


Eligibility criteria:
inclusion criteria: * previously participated in the "memantine and comprehensive, individualized, patient centered management of alzheimer's disease: a randomized controlled trial" study.
healthy eating patterns during a lifestyle intervention

Conditions: Obesity; Weight Loss

Summary: the purpose of this study is to address the gap in knowledge regarding the relationship between eating frequency and weight loss.

little intervention research has been conducted to examine the influence of eating frequency (ef) on weight loss. it has been hypothesized an increased ef improves appetite control, assisting with better regulation of energy intake, thus decreasing body mass index. unfortunately, outcomes have not shown greater appetite control with increased ef. instead, trends favor a lower ef reducing energy intake thereby producing greater weight loss than a higher eating frequency. thus, a lower eating frequency may lower energy intake via behavioral mechanisms. at thit time no research has examined the behavioral mechanisms that may mediate the relationship between a lower eating frequency and superior adherence to an energy-restricted diet.

Eligibility criteria:
inclusion criteria: * age between 18 and 65 years * healthy overweight and obese men and women * body mass index (bmi) between 27 and 45 kg/m squared exclusion criteria: * report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the physical activity readiness questionnaire (par- q) * report being unable to walk for 2 blocks (1/4 mile) without stopping * are currently participating in a weight loss program and/or taking weight loss medication or lost \> 5% of body weight during the past 6 months * diagnosed with type 1 or 2 diabetes * have had bariatric surgery or are planning to have bariatric surgery in the next 4 months * intend to move outside of the metropolitan area within the time frame of the investigation * are pregnant, lactating, \< 6 months post-partum, or plan to become pregnant during the investigation

Keywords: eating frequency
longitudinal changes in achilles tendon and medial gastrocnemius muscle architecture during a 156-km ultradistance trail running event

Conditions: Achilles Tendinopathy; Calf Injury; Sport Injury; Lower Limb Injury

Summary: this study aimed to assess the longitudinal changes in triceps surae muscle-tendon architecture to an ultra distance trail running. experienced trail runners (n=55, 78% men, age: 45.2 \[13.5\] years) participated in a 156-km trail run (6000m climbing) consisting in six 26-km laps. the resting architectural properties of triceps surae muscle-tendon were measured using ultrasound imaging for achille tendon cross-sectional area (at csa), medial gastrocnemius muscle pennation angle, thickness, length and fiber length. measurements were performed the day before the race (baseline), at 52-km (t1), at 104-km (t2), at 156-km (t3) and 12 hours after the race (h12).


Eligibility criteria:
inclusion criteria * experienced runners voluntarily participating in the trail scientifique de clécy (156 km/6000 d+) * participants who had already completed 2 ultratrail races (+160 km and -160 km), at least one of them in the past 24 months; the participants had to justify their events and rankings * participants affiliated with a social security system or those who were a beneficiary of such a system * participants who could speak and read the french language * participants with the ability to physically participate in the ultraendurance race * participants with the ability to provide written consent for participation in the study exclusion criteria * participants with cardiac or extracardiac contraindications to intense physical activity * participants who had run a mountain ultramarathon (160 km) after september 2, 2021 * pregnant or breastfeeding women * minor participants * participants included in another biomedical research protocol during this study * participants with recent muscular and orthopedic injuries, limiting running for \<15 days * participants with a history of ankle joint surgery (eg, arthrodesis) * participants with a history of foot or ankle surgery * participants with lower-limb pathology or trauma
denosumab vs zoledronic acid and osteoporotic compression fracture

Conditions: Denosumab vs Zoledronate

Summary: bone mineral density and function at 1 year after screw fixation with denosumab vs zoledronic acid for osteoporotic vertebral compression fractures: a parallel double-blind randomized controlled clinical trial

conduct a single-center, double-blind, randomized controlled clinical trial according to clinical trial reporting standards (consort). bone mineral density and function of osteoporotic vertebral compression fracture (ovcf) were compared 1 year after screw internal fixation with denosumab vs zoledronic acid in shenzhen people's hospital from september, 2021 to november, 2022. the study was approved by shenzhen people's hospital and informed consent was signed.

Eligibility criteria:
inclusion criteria: * must be age between 40 and 90 years old * x-ray diagnosis of 1-2 vertebral compression fractures * dual eneragy x ray test for bone mineral density t value less than -1 * fracture history lasted within 6 weeks * must be mri showed bone marrow edema of injured segment * must be lower back pain, local spines tenderness exclusion criteria: * must be able to have no posterior vertebral wall fracture * must be able to have no patients with intervertebral fissure * must be able to have no infection * must be able to have no malignancy * must be able to have no neurological dysfunction * must be able to have no calcium level ≤2.13 mmol/l * must be able to have no previous use of anti-osteoporosis drugs * must be able to have no inability to perform magnetic resonance imaging * must be able to have no prior back surgery * must be able to have no other established contraindications for elective surgery
efficacy of twice weekly hemodialysis in patients with residual kidney function

Conditions: Hemodialysis; Kidney Failure, Chronic

Summary: the study will determine the efficacy of twice weekly hemodialysis in patients with residual kidney function.

hemodialysis patients who have residual kidney function will undergo two 4-week study (twice weekly versus thrice weekly hemodialysis). blood, urine, and dialysate samples will be collected at the end of each study period to determine adequacy of treatment and to assess uremic solute levels. participants will complete quality of life questionnaires and cognitive paper tests. food records and medications may be monitored.

Eligibility criteria:
inclusion criteria: * stable dialysis patients able to provide consent exclusion criteria: * use of antibiotics for last two months or expected antibiotic use * recent hospitalization or other event resulting in instability of food intake * residual kidney function \< 2.5 ml/min
the metabolic response to reduced branched-chain amino acids in humans

Conditions: Diabetes; Obesity; Insulin Resistance

Summary: branched-chain amino acids (bcaas) are essential nutrients that the body obtains from proteins found in food, especially meat, diary products, and legumes. data from rodent studies suggest that reduction of dietary bcaas will promote fat mass loss and improved control of blood glucose. the purpose of this study is to test if reduction of dietary bcaas without reducing calorie intake will lead to similar metabolic benefits in humans. here the investigators test the feasibility of reducing dietary bcaas using bcaa-free meal replacement beverages for two months.

this study, which will be completed over three months, involves replacing two meals a day with meal replacement beverages for two months, with a one month follow-up visit. these beverages will be made up by subjects using either a complete protein powder or bcad2, a bcaa-free medical food. participants will complete food diaries at baseline and at one month intervals during the study, and compliance will be assessed via food diaries, weekly telephone contact, and measuring returned food powder.

Eligibility criteria:
inclusion criteria: 1. male between the age of 35 - 65 2. bmi between 28 - 35 (mildly obese/overweight) 3. fasting glucose level of 101 - 125 mg/dl 4. able and willing to give written informed consent 5. stable weight (within 5 lbs. for at least 3 months) 6. not taking (or willing to cease taking) over the counter vitamin/mineral supplements 7. not planning to begin an exercise or diet program exclusion criteria: 1. female 2. outside required age range of 35 - 65 3. bmi not within range of 28 - 35 4. fasting glucose not within range of 101 - 125 mg/dl 5. use of prescription medications for diabetes or weight-loss 6. use of and unwillingness to discontinue over the counter supplements (e.g. cinnamon, chromium, protein powders) or weight loss beverage or meal plans (e.g. slimfast or jenny craig). 7. low baseline albumin or pre-albumin levels (below normal reference range) 8. significant anemia (hemoglobin \< 11 g/dl) 9. known bleeding disorder or platelet dysfunction 10. already eating a low protein diet (less than 14% total caloric intake from protein), as calculated from food diaries provided by subjects 11. participating in intensive exercise training program (high to moderate intensity exercise greater than 210 minutes per week) or planning to start new exercise program during study period. 12. significant co-morbidities (including kidney disease, liver disease, gi disease, cardiovascular disease, respiratory disease, malnutrition, substance abuse, psychiatric disease, or a diagnosed eating disorder). 13. planned smoking cessation or attempt at smoking cessation during study period 14. inability to tolerate meal replacement beverages due to palatability 15. recent weight loss (\> 5 lbs within 3 months). 16. bariatric surgery, gastric banding or liposuction 17. current or past (within 1 year) use of illicit drugs 18. claustrophobia
fascial distortion model in tension type headache

Conditions: Postural; Defect; Tension-Type Headache; Pain, Neck; Craniovertebral; Syndrome; Proprioceptive Disorders

Summary: tension-type headache is a headache that starts from the cervical and suboccipital regions, spreads from the back of the head to the parietal, frontal and temporal regions, and is felt in the form of compression, pressure and heaviness. increased muscle and fascia tone in the cervical and cranial region, together with active trigger points and factors that trigger pain, cause tension-type headache. head and neck fascia serves as an important proprioceptive structure in our body. abnormal inputs from mechanoreceptors and structures around the joint cause deterioration in joint position sense. this study was planned to investigate the effects of the new facial distortion model on pain intensity, cervical posture and joint position sense, unlike the manual techniques used in previous studies in tension-type headache.

this study was planned as a randomized controlled trial to investigate the effect of fascial distortion model on pain severity, cervical posture and joint position sense in patients with tension headache. individuals with tension-type headache will be divided into control (n=15) and study group (n=15) by simple random method. fascial distortion modeling will be applied to the study group for a total of 4 weeks, one session a week for 30 minutes. no application was made to the control group. evaluations will made for all individuals twice, at baseline and after 4 weeks. pain severity of individuals was evaluated with vas and mcgill-melzack pain scale, cervical posture with posturescreen mobile application, joint position sense with laser cursor-assisted angle repetition test.

Eligibility criteria:
inclusion criteria: * diagnosis of tension-type headache, * the ages of 20-50 years, * must be headache complaint for at least 6 months, * pain is at least 4 on the visual pain scale. exclusion criteria: * diagnosis of ervical disc herniation, * diagnosis of sinusitis, migraine and vertigo, * diagnosis of scoliosis, * diagnosis of radiculopathy, * having a history of surgery tumor, cyst or similar findings, having received any physical therapy for the cervical region before, having any psychological disorder it is the use of any painkillers during the treatment.